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Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

NCT00945022 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-06-09

No results posted yet for this study

Summary

Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery.

The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.

Conditions

  • Oral Dryness
  • General Surgery

Interventions

DEVICE

wetting lips following surgery using anesthesia

The investigator will position the Lipsus device in accordance with the instructions for use

Sponsors & Collaborators

  • IMD Tech Ltd

    lead INDUSTRY

Principal Investigators

  • Alexander Yuskavitch, Dr. · Shaari Zedek Medical Center, Jerusalem

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945022 on ClinicalTrials.gov